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Clinical and Translational Science Awards (CTSA) Comparative Effectiveness Research Key Function Committee
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Committee, Work group, Advisory group, or Task Force
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AHRQ, HRSA
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NCATS, CC, NCCAM, NCI, NHLBI, NIA, NIDDK, NIMH
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The Comparative Effectiveness Research (CER) Key Function Committee builds the field of CER for patient centered outcomes research by creating a learning community across Clinical and Translational Science Award (CTSA) institutions, spurring the development of methods, expanding training and education, promoting community and public engagement, and application of CER findings and sharing successes and lessons learned. Through collaborative work products, the CER Key Function Committee facilitates the generation and synthesis of evidence about alternative interventions that results in actionable findings for policymakers, clinicians, patients, and purchasers to use in improving the quality and outcomes of health care.
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Clinical and Translational Science Awards (CTSA) Education and Career Development Key Function Committee
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Committee, Work group, Advisory group, or Task Force
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FDA
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NCATS, CC, NCCAM, NCI, NHLBI, NIAAA, NIDCR, NIDDK, NIMH, NINR
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The CTSA Education and Career Development Key Foundation Committee supports interdisciplinary education, training, and career development in Clinical and Translational Science. The committee provides a forum to discuss novel concepts, methodologies and approaches in curriculum development, program development, clinical research training and recruiting. The annual Translational Science Meetings for scholars provide networking opportunities for junior investigators to interact with the Association for Clinical Research Training, Association of American Medical Colleges, Industry, and federal agencies which share complementary training programs
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Clinical and Translational Science Awards (CTSA) Regulatory Knowledge Key Function Committee
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Committee, Work group, Advisory group, or Task Force
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FDA
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NCATS, CC, NCI, NHGRI, NIAID, NIBIB, NICHD, NIDDK, NLM, OD
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The CTSA Regulatory Knowledge Key Function Committee will promote the protection of human subjects and facilitate communicating shared regulatory compliance issues and improvements. Clinical research regulation issues addressed may include the provision of integrated training, services, or tools for protocol and informed consent authoring and translation, adverse event reporting, safety and regulatory management and compliance, etc. CTSAs can disseminate best practices that reduce or remove institutional impediments to clinical and translational research which would enhance inter-institutional collaborations. Regulatory support provided through a CTSA should assist investigators in their regulatory process and documentation requirements. The CTSA Regulatory Knowledge Key Function Committee will also ensure that collaborative clinical and translational research activities are facilitated, whether by procedures or best practices, in developing the Regulatory Support interactions with the IRB and compliance office without loss of participant protections.
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Clinical Data Acquisition Standards Harmonization (CDASH) Initiative led by Clinical Data Interchange Standards Consortium (CDISC)
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Committee, Work group, Advisory group, or Task Force
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FDA
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NCI
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Harmonization efforts to standardize elements for data capture.
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Clinical Decision Support (CDS) Federal Collaboratory and Inventory of Federal Clinical Decision Support Activities
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Committee, Work group, Advisory group, or Task Force
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AHRQ, CDC, HRSA, IHS, OS
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NLM, CC
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A federal community of interest focused on clinical decision support, and a compilation of project summaries describing CDS activities that are either funded by the US Federal government, or that are being executed by agencies of the government. The term Clinical Decision Support (CDS) describes a variety of tools and technologies that are used within electronic clinical information systems to improve the quality, safety, efficiency and effectiveness of patient care. CDS provides clinicians, staff, patients, and other key decision makers with knowledge and person-specific information, intelligently filtered at appropriate times, to enhance health and health care. CDS encompasses computerized alerts and reminders, clinical guidelines, order sets, order entry feedback, patient data reports and dashboards, documentation templates, diagnostic support, and the presentation of contextually relevant reference information within clinical information systems. NLM has submitted to the Collaboratory and Inventory summaries of NLM projects involving Clinical Decision Support.
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Clinical Investigator Interagency Working Group for the Development of Antiviral Influenza Therapeutics
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA
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NIAID
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Objective: To discuss a range of issues relevant to the development of antiviral drugs for the treatment of influenza.
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Clinical Islet Transplantation Consortium
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Research Initiative
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CMS, FDA
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NIDDK, NIAID
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"The Clinical Islet Transplantation (CIT) Consortium is a network of clinical centers and a data coordinating center established in 2004 to conduct studies of islet transplantation in people with type 1 diabetes.
Studies conducted by the CIT Consortium will focus on improving the safety and long-term success of methods for transplanting islets, the insulin-producing cells of the pancreas, in people whose own islets have been destroyed by the autoimmune process that characterizes type 1 diabetes. One clinical trial, in particular, is studying the efficacy of islet transplantation after kidney transplantation. Participants may include Medicare beneficiaries. This study was mandated in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. "
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CMS-NIH Collaborations on CMS Innovation Center
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Committee, Work group, Advisory group, or Task Force
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CMS
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OD, CC, NCCAM, NCI, NCATS, NEI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIMH, NIMHD, NINDS, NINR, NLM
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The Innovation Center aims to test innovative payment and service delivery models to reduce program expenditures under Medicare, Medicaid and CHIP, while preserving or enhancing the quality of care furnished. CMS and NIH have been discussing potential approaches to NIH collaboration with various Innovation Center Initiatives including the Health Care Innovation Challenge and the State Innovation Program.
The Health Care Innovation Challenge, released in November 2011, makes up to $1 billion available, and will be awarded to innovative projects testing creative approaches to delivering high-quality health care services, at lower cost, with priority to projects that hire, train, and deploy new types of health care workers.
The State Innovation Program (SIIP) FOA was released in January, 2012, offering States the opportunity to participate directly in multi-payer delivery system strategies, and to design models that achieve the radical shift towards prevention. The program aims to accelerate healthcare system transformation and reduce healthcare cost. The initiative has a five year program life cycle with a total budget of $1.3 billion. NIH has proposed high impact areas and results that could be rapidly implemented on larger scales, including: diabetes (i.e. the Diabetes Prevention Program), schizophrenia (i.e. RAISE trial), stroke, lung cancer (i.e. the National Lung Cancer Spiral CT Screening Trial), and prevention of pre-term birth.
Currently, CMS and NIH are collaborating to develop randomized controlled clinical policy trials: novel, low cost practical trials that can drive reform. NIH, in collaboration with CMS is developing a PAR on Large, Inexpensive, Pragmatic Randomized Controlled Policy Trials, as a new way to develop evidence-based policy. This solicitation will represent a first steps to jointly leveraging CMS and NIH strengths. Simple, pragmatic trials, with minimal inclusion and exclusion criteria, will assist NIH and CMS in capturing patients similar to the ones seen in everyday practice, and help capture information on large populations with multiple co-morbidities.
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CMS-NIH Data Access Committee
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Committee, Work group, Advisory group, or Task Force
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CMS
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OD, CC, NCCAM, NCI, NCATS, NEI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIMH, NIMHD, NINDS, NINR, NLM
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Much scientific and policy value could be generated from observational studies which could be based, at least in part, on available CMS data. NIH and CMS established a Data Access Committee to identify and pursue immediate priorities. The Committee has been meeting monthly for the past year. Working Groups are focusing on: a) Identification of data and endpoints in NIH supported trials which would be useful to CMS; b) Identification of types of CMS data and linkages that could prove useful to NIH-supported investigators; c) Design and operation of data enclaves, trusted entities status, and other data security measures; d) Strategies for informing communities of available CMS data, and CMS staff contacts; e) Anticipating natural experiments (e.g. health care reform, geographic variation)
Current initiatives include planning a workshop on enclave development and data linkage, aimed at gathering input from researchers who use CMS data; exploring options for jointly establishing a virtual laboratory at Oak Ridge National Labs, and developing an Early Alert System for CMS regarding Anticipated High Impact Clinical Research Findings, using clinicaltrials.gov.
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CMS-NIH Senior Leadership Forum
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Committee, Work group, Advisory group, or Task Force
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CMS
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OD, NHLBI, NIA
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A “CMS-NIH Senior Leadership Forum” comprised of NIH Director Francis Collins, CMS Administrator Don Berwick, and Senior Staff from both agencies, convened quarterly throughout 2011. The Forum aimed to: a) Oversee establishment of joint collaborations to enable rapid translation and implementation of NIH-funded research into clinical practice; b) Stimulate collaboration between NIH and the “CMS Innovation Center” to forge pilot projects; c) Undertake efforts to rapidly identify, design, and execute studies to inform high-priority CMS questions; and d) Enhance research access to CMS data, including making available the establishment of secure CMS data enclaves to qualified NIH investigators.
The two agencies look forward to planning a series of important new initiatives. To ensure a successful, longstanding collaboration, a “CMS-NIH Brain Trust” is under development, intended to span NIH ICs and CMS Centers, and to allow for interagency brainstorming. (ATTACHMENT) The Brain Trust will engage in dialogue on CMS needs and NIH research prioritization, and forge joint efforts to develop innovative trials and coverage mechanisms. Working Groups have been/are being, established to focus on data access, health economics, multiple chronic conditions, evaluation, and collaborating with the CMS Innovation Center.
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